Panacea Biotec - Senior Manager/Assistant General Manager - Regulatory Affairs

Position: Sr. Manager / AGM Regulatory Affairs

Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)

Experience: 13 to 16 years in Regulatory Affairs (vaccines/biologicals)

Role: The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory compliance/audit support. The role ensures accurate and compliant representation in dossiers, while guiding strategy for regulatory filings, variations, and lifecycle management across multiple regions.

Key Responsibilities:

- Deep expertise in vaccine/biological regulatory affairs, dossier preparation, and lifecycle management.

- Strong track record in WHO PQ filings, country registrations in LatAm & Africa, and handling audits/inspections.

- Hands-on experience in CMC data review, comparability, and technology transfer from development to commercial sites.

- Skilled in managing confidential proprietary know-how within regulatory frameworks.

- Leadership ability to guide teams, engage with regulators, and drive cross-functional compliance.

- Prepare and review CTD/ACTD/eCTD dossiers, ensuring accuracy and compliance with regional requirements.

- Confidential Know-How Custodian: Manage proprietary technical information (cell substrates, seeds, process steps, validation data, excipients, DS/DP composition) and ensure controlled incorporation into dossiers.

- Lead post-approval variations, change controls, and license renewals/maintenance across client countries.

- Drive pre-submission strategy, dossier compilation, regulatory liaison, and post-PQ lifecycle management.

- Provide country-specific CMC requirements to R&D; guide teams on comparability, validation, and regulatory responses.

- Ensure regulatory guidance and documentation compliance during product/site transfers/Tech transfer.

- Prepare responses to regulatory queries, coordinate with bulk suppliers for PAC filings, and represent the company during inspections.

- Mentor and upskill subordinates; build regulatory capability aligned to evolving global requirements.

Liaison with Regulatory Authorities:

Candidate Profile:

- Proven expertise in vaccine/biological product regulatory affairs, including WHO PQ and multi-regional registrations.

- Strong knowledge of CMC, comparability, process validation, and lifecycle change management.

- Experience liaising with regulators, managing audits, and preparing PSURs/SAE submissions.

- Ability to lead teams, safeguard confidential technical know-how, and drive regulatory compliance across geographies.